Accessory kit — Class II medical device recall Z-0544-2020
Ongoing recall by Abbott Gmbh & Co. KG, reported 2019-12-04, distributed nationwide. Potential reliability issue with the Alinity ci series Level Sensor, Bulk Solution. The development of environ
| Recall number | Z-0544-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Abbott Gmbh & Co. KG, Wiesbaden, Germany |
| Recall initiated | 2019-09-16 |
| Classified | 2019-11-22 |
| Reported by FDA | 2019-12-04 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BD, BE, BG, BH, BR, CA, CH, CL, CN, CO, CZ, DE, DK, DZ, EE, ES, FI, FR, GB, GR, GT, HK, HR, ID, IE, IL, IN, IT, JM, JO, JP, KE, KR, KW, LB, LT, LV, MX, MY, NL, NO, NZ, OM, PH, PK, PL, PT, RO, RS, RU, SA, SE, SG, SI, SK, TH, TR, TT, TW, UY, VN, ZA |
| Quantity | 3,271 units |
| Reason classes | packaging |
Product
Accessory kit, Alinity i containing Alinity ci Level Sensor, Bulk Solution
Reason for recall
Potential reliability issue with the Alinity ci series Level Sensor, Bulk Solution. The development of environmental stress on the bulk solution level sensor can cause cracks.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0544-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.